Disflatyl 40mg/ml drops oral

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

simethicone

Available from:

Legacy Pharmaceuticals Switzerland GmbH

ATC code:

A03AX13

INN (International Name):

simethicone

Dosage:

40mg/ml

Pharmaceutical form:

drops oral

Units in package:

glass bottle 30ml

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2015-04-08

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Disflatyl® Drops
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains 40 mg of Simeticone(activated
dimethylpolysiloxane), 1 ml 27 ± 3 drops.
Excipients: For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Drops for oral use
Homogeneous milk-white emulsion.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Disflatyl® drops are used for the symptomatic treatment of all types
of excessive gas formation or
accumulation
in
the
gastrointestinal
tract
such
as
flatulence,
bloating,
meteorism,
including
-
postoperative
meteorism,
aerophagy.
Administration
of
Disflatyl®
drops
reduces
the
feeling
of
postprandial fullness and a sense of tension in the abdomen.
Disflatyl® drops are usedon prescription for the preparation for
endoscopic, radiological, ultrasound or
sonographic investigation of the stomach and / or bowel for passage of
flatus from the gastrointestinal
tract.
_ _
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
1.
Symptomatic
treatment
of
all
types
of
excessive
gas
formation
and
accumulation
in
the
gastrointestinal tract.
_Adults:_ Take 25‐50 drops, possibly with a little fluid, after
every meal and before retiring to bed.
_Schoolchildren:_ Take 15‐20 drops, possibly with a little fluid,
after every meal and before retiring to bed. _ _
_Babies and infants(up to 6 years of age):_ About 10‐15 drops 2‐3
times a day in the bottle or after meals.
The children of the first year of life and pre-school children
(children up to age 6): 10-15 drops 2-3 times
a day with meals or after meals.
2. Preparation of the stomach and / or bowl investigation.
50 drops 3-4 times daily for two days prior to the study, 50 drops
morning fasting study day and 50
drops directly before the investigation.
_Shake the bottle thoroughly before use! _
4.3 CONTRAINDICATIONS
Ileus, obstructive gastrointestinal colic and vomiting. Consult a
physician in any of these cases. Known
hypersensitivity to one or more of the above mentioned ingredi